A study of the effects of oxytocin and carbetocin on the heart

The Clinical Carbetocin Myocardium Trial - CarbetocinHeart2014

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000507-27-NO

Enrollment

400

Registered

2014-07-02

Start date

2014-09-05

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy MedDRA version: 17.0 Level: SOC Classification code 10036585 Term: Pregnancy, puerperium and perinatal conditions System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions MedDRA version: 17.0 Level: LLT Classification code 10048862 Term: Cesarean section System Organ Class: 100000004865

Interventions

Trade Name: Pabal Product Name: Pabal Pharmaceutical Form: Injection Trade Name: Syntocinon Product Name: Syntocinon Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Planned cesarean delivery of single baby Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Cardiac diseases, intolerance to IMPs, placental diseases.

Design outcomes

Primary

Measure	Time frame
Main Objective: Cardiac biomarkers may increase after injection of oxytocin. Carbetocin, a new synthetic oxytocin receptor agonist, may have similar effects. This study compares the two drugs in clinical use for treatment and prophylaxis of atonic uterine bleeding;Secondary Objective: Group differences in blood loss and side effects between the two drugs ;Primary end point(s): Troponin I. ;Timepoint(s) of evaluation of this end point: 0, 4, 12, 24, and 48 h	—

Measure

Time frame

Main Objective: Cardiac biomarkers may increase after injection of oxytocin. Carbetocin, a new synthetic oxytocin receptor agonist, may have similar effects. This study compares the two drugs in clinical use for treatment and prophylaxis of atonic uterine bleeding;Secondary Objective: Group differences in blood loss and side effects between the two drugs ;Primary end point(s): Troponin I. ;Timepoint(s) of evaluation of this end point: 0, 4, 12, 24, and 48 h

—

Secondary

Measure	Time frame
Secondary end point(s): Troponin T, proBNP, CK, CK-MB, Sodium, and Potassium. Adverse events. Pain.;Timepoint(s) of evaluation of this end point: 0, 4, 12, 24, and 48 h	—

Countries

Norway

Contacts

Public ContactDepartment of Anesthesiology

Oslo University Hospital

lrossela@ous-hf.no4723073700

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026